Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
18 Years
N/A
Both
Cystic Fibrosis
Trial Information
Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
The goal of this clinical study is to advance the acceptance of new biomarkers designed to
detect drug-induced kidney injury in clinical trials.
The Kidney Safety Project is being conducted at four major medical centers:
- University of Southern California
- University of Minnesota
- MD Anderson Cancer Center
- Dana-Farber Cancer Institute.
Blood and urine samples will be collected from patients undergoing treatment with either
cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the
proximal tubule of the kidney. Aminoglycosides are a common antibiotic drug taken by
patients with cystic fibrosis. Cisplatin is a common chemotherapy drug taken by patients
with head and neck cancer.
The Aminoglycoside Study of the Kidney Safety Project is being conducted at the University
of Southern California and the University of Minnesota and aims to evaluate aminoglycoside
induced acute kidney injury in patients with cystic fibrosis.
The companion study, the Cisplatin Study of the Kidney Safety Project, is being conducted at
the MD Anderson Cancer Center and the Dana-Farber Cancer Institute and aims to evaluate
cisplatin induced acute kidney injury in patients with head and neck cancer.
The data from the Kidney Safety Project, from both the Aminoglycoside Study and the
Cisplatin Study, will be combined for determination of the best biomarkers for predicting
drug-induced acute kidney injury.
Inclusion Criteria
Inclusion criteria:
1. Males and females ≥ 18 years of age.
2. Documentation of CF diagnosis as evidenced by one or more clinical features
consistent with the CF phenotype and one or more of the following criteria:
- Sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine
iontophoresis test.
- Two well-characterized mutations in the cystic fibrosis transmembrane
conductance regulator (CFTR) gene; or
- Abnormal nasal potential difference.
3. Hospitalized and initiated on systemic antibiotic therapy for treatment of an acute
pulmonary exacerbation.
4. Willingness and ability to comply with study procedures and study restrictions.
5. Ability to provide written informed consent.
Exclusion criteria:
1. Chronic kidney disease defined by microalbuminuria (> 30 mcg/mg creatinine) or eGFR <
60 mL/min/1.73m2.
2. Receiving medications known to alter the tubular secretion of creatinine (e.g.
trimethoprim, cimetidine).
3. Hospitalized for treatment of an acute pulmonary exacerbation or received intravenous
aminoglycoside antibiotics within 3-months of study entry.
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Principal Investigator
Paul Beringer, PharmD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Southern California
Authority:
United States: Institutional Review Board
Study ID:
Kidney Safety - Aminoglycoside
NCT ID:
NCT01543620
Start Date:
February 2012
Completion Date:
September 2013
Related Keywords:
- Cystic Fibrosis
- kidney safety
- biomarkers
- serum creatinine
- BUN
- cystic fibrosis
- head and neck cancer
- renal injury
- drug induced acute kidney injury
- aminoglycoside
- cisplatin
- nephrotoxicity
- biomarker qualification
- Cystic Fibrosis
- Fibrosis
Name | Location |
|---|---|
| University of Southern California | Los Angeles, California 90033 |
| University of Minnesota - Cystic Fibrosis Center | Minneapolis, Minnesota 55455 |
